Status:
COMPLETED
To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Pharmacokinetics of Mirabegron
Healthy Subjects
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol change whilst being do...
Detailed Description
The study is an open label, single center study. All subjects are genotyped for CYP2D6 before the study. Genotype expression is confirmed by dextromethorphan phenotyping. Part I: The pharmacokinetic ...
Eligibility Criteria
Inclusion
- For Part I:
- Subject genotyped and phenotyped for CYP2D6
- Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2
- For Part II:
- Subject genotyped and phenotyped as extensive metaboliser for CYP2D6
- Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2
Exclusion
- Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- QTc intervals of \>430 msec
- Abnormal pulse rate measurement (\<40 or \>90 bpm) taken by manual counting at the pre-study visit after subject has been resting in supine position for 5 min
- Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows: systolic blood pressure \<95 or \>160 mmHg; diastolic blood pressure \<40 or \>95 mmHg
- Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and/or a fall of ≥ 20 mmHg in systolic blood pressure after 2 min standing (preceded by 5 min. supine rest) and/or an increase in pulse rate of ≥ 20 bpm
- Regular use of any prescribed or OTC drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to admission to the Research Unit
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01478490
Start Date
September 1 2002
End Date
November 1 2002
Last Update
April 10 2014
Active Locations (1)
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1
PRA International (former Pharma Bio-Research)
Zuidlaren, Netherlands, 9471 GP